Gliclada

Package leaflet: Information for the patient

Gliclada, 60 mg, modified-release tablets
Gliclazide
Read the entire leaflet carefully before taking this medicine.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• It may harm other people, even if their symptoms are the same.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Gliclada is and what it is used for
2. What you need to know before taking Gliclada
3. How to take Gliclada
4. Possible side effects
5. How to store Gliclada
6. Contents of the pack and other information

1. What Gliclada is and what it is used for

Gliclada is a medicine that lowers blood glucose levels (it is an oral antidiabetic agent belonging to the sulfonylurea derivatives group).
Gliclada is used in the treatment of a certain type of diabetes (type 2 diabetes) in adults, when diet, physical exercise, and weight reduction alone are insufficient to maintain normal blood glucose levels.

2. Important information before using Gliclada

When not to use Gliclada:

• if the patient is allergic to gliclazide or any of the other components of this medicine (listed in section 6), other drugs of the same group (sulfonylurea derivatives), or other sulfonamides with blood glucose-lowering activity;
• if the patient has insulin-dependent diabetes (type I);
• if ketone bodies and sugar are present in the urine (this may indicate diabetic ketoacidosis), pre-comatose or comatose states;
• if the patient has severe kidney or liver disease;
• if the patient is taking medicines used to treat fungal infections (miconazole, see section "Other medicines and Gliclada");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before taking Gliclada, you should inform your doctor or pharmacist.
You must follow the treatment plan recommended by your doctor to achieve the desired blood glucose levels. This means not only taking the medicine regularly, but also adhering to a diet, engaging in regular physical exercise, and, if necessary, reducing body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) levels is required, as well as periodic measurement of glycated hemoglobin (HbA1c).
The risk of low blood glucose (hypoglycemia) may be increased during the first weeks of treatment. Therefore, particularly close medical supervision is essential.
Low blood glucose (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient is fasting;
• the patient is undernourished;
• the patient changes their diet;
• the patient increases physical activity without adequate carbohydrate intake;
• the patient consumes alcohol, especially when skipping meals;
• the patient is taking other medicines or natural supplements at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction);
• kidney or liver function is severely impaired.

If the patient has low blood glucose, the following symptoms may occur:
headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression,
reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or
visual disturbances, tremor, sensory disturbances, dizziness, weakness.
Other symptoms may include: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating to adjacent areas (angina pectoris).
If blood glucose continues to fall, severe confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, loss of consciousness may occur, potentially leading to coma. The clinical picture of severe hypoglycemia may resemble stroke.
In most cases, symptoms of low blood glucose resolve quickly when the patient consumes sugar, e.g., glucose tablets, sugar cubes, sweet juice, or sweetened tea.
Therefore, it is important to always carry some sugar-containing products (glucose tablets, sugar cubes).
Note that artificial sweeteners are ineffective. Contact your doctor or nearest hospital if consuming sugar does not help or if symptoms recur.
Symptoms of low blood glucose may not appear, may be mild or develop slowly, or the patient may not be aware that blood glucose has dropped. This may occur in elderly patients or in those taking certain medications (e.g., drugs acting on the central nervous system or beta-blockers).
It may also occur in patients with certain endocrine disorders (e.g., certain thyroid or anterior pituitary disorders, or adrenal insufficiency).
In stressful situations (e.g., accidents, surgical procedures, fever, etc.), the doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur if gliclazide has not sufficiently lowered blood glucose levels, if the patient has not followed the treatment plan recommended by the doctor, if the patient has taken St John's wort (Hypericum perforatum) (see section "Gliclada with other medicines"), or during particularly stressful situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
Glucose metabolism disturbances (low and high blood glucose), especially in elderly patients, may occur when gliclazide is taken concomitantly with antibiotics known as fluoroquinolones. In such cases, the doctor will inform the patient about the importance of monitoring blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) has been diagnosed in the patient or in a family member, hemoglobin levels may decrease and red blood cells may break down (hemolytic anemia). Consult your doctor before taking this medicinal product.

Children and adolescents
Gliclada is not recommended for use in children due to lack of data.

Other medicines and Gliclada
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The blood glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood glucose may occur, when any of the following medicines are taken:

• other medicines used to treat high blood glucose (oral antidiabetic drugs, GLP-1 receptor agonists, or insulin);
• antibiotics (sulfonamides, clarithromycin);
• medicines used to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril);
• medicines used to treat fungal infections (miconazole, fluconazole);
• medicines used to treat stomach or duodenal ulcers (H2-receptor blockers);
• medicines used to treat depression (MAO inhibitors);
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause increased blood glucose:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or administered during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines used to treat breast disorders, severe menstrual bleeding, and endometriosis (danazol);
• St John's wort (Hypericum perforatum) preparations.

Glucose metabolism disturbances (low and high blood glucose), especially in elderly patients, may occur when Gliclada is taken concomitantly with antibiotics known as fluoroquinolones.
Gliclada, modified-release tablet, may enhance the effect of anticoagulant medicines (e.g., warfarin).
Consult your doctor before starting any other medicinal product.
If the patient is admitted to hospital, they should inform the medical staff that they are taking Gliclada.

Gliclada with food, drink, and alcohol
Gliclada, modified-release tablet, can be taken with food and non-alcoholic beverages.
Alcohol consumption is not recommended, as it may alter diabetes control in an unpredictable way.

Pregnancy and breastfeeding
Gliclada is not recommended during pregnancy. If the patient is pregnant or breastfeeding, suspects she is pregnant, or plans a pregnancy while taking this medicine, she should inform her doctor, who may recommend a more appropriate treatment.
Gliclada must not be used during breastfeeding.

Driving and operating machinery
If blood glucose is too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or react may be impaired. Remember that the patient may pose a risk to themselves or others (e.g., when driving a car or operating machinery). Consult your doctor about the ability to drive:

• if low blood glucose (hypoglycemia) occurs frequently;
• if symptoms of low blood glucose (hypoglycemia) are minimal or absent.

Gliclada, modified-release tablet contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Gliclada

Dosage
Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
please consult your doctor or pharmacist.
The dosage is determined by the doctor, based on blood and urine glucose levels.
Any changes related to external factors (e.g. weight loss, lifestyle changes, stress) or improved
blood glucose control may require adjustment of gliclazide dosage.
The recommended dose is half to two tablets (maximum 120 mg) taken once daily with breakfast.
The dose depends on the body's response to treatment.
In combination therapy with Gliclada modified-release tablets and metformin, an alpha-glucosidase
inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin,
the appropriate dose of each medicine will be individually determined by the doctor.
If the patient notices high blood glucose levels despite taking the medicine as prescribed, they should
consult their doctor or pharmacist.

Route and method of administration
For oral use.
The tablet may be divided into equal doses.
Swallow half or a whole tablet(s) at once. Do not chew or crush.
Take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day).
Always eat a meal after taking the tablet(s).

Overdose of Gliclada
If too many tablets are taken, contact a doctor immediately or go to the nearest hospital. Symptoms of
overdose are symptoms of low blood sugar (hypoglycaemia), as described in section 2. In such cases,
consuming sugar (4 to 6 sugar cubes) or drinking a sweet beverage, followed by a snack or meal, may
help. If the patient is unconscious, contact a doctor immediately and call emergency services. The
same applies if someone (e.g. a child) accidentally takes this medicine. Do not give food or drinks to
an unconscious person.
Ensure that someone is always informed in advance who can call a doctor in case of an emergency.

Missed dose of Gliclada
It is important to take the medicine every day, as regular use ensures better effectiveness.
However, if a dose of Gliclada is missed, the next dose should be taken at the usual time. Do not take
a double dose to make up for a missed dose.

Stopping Gliclada
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Discontinuing treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the
risk of diabetes complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.

Common (occurring in fewer than 1 in 10 people):
The most commonly observed adverse effect is low blood sugar (hypoglycaemia).
Subjective and objective symptoms are described in the section "Warnings and precautions".
If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness or coma.
If low blood sugar is significant or prolonged, even if temporarily controlled by sugar intake, you should contact your doctor immediately.

Uncommon (occurring in fewer than 1 in 100 people):
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation. These symptoms may be reduced by taking Gliclada modified-release tablet with food as recommended.

Rare (occurring in fewer than 1 in 1000 people):
Blood disorders
Decreased number of blood cells (e.g. platelets, red and white blood cells) may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after discontinuation of treatment.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties) have been observed. The rash may progress to extensive blistering or lead to skin peeling. Very rarely, symptoms of severe hypersensitivity reactions (DRESS) have been reported, initially presenting as influenza-like symptoms and facial rash which subsequently spreads, accompanied by high fever.

Liver disorders
Isolated cases of impaired liver function, which may cause yellowing of the skin and eyes (jaundice), have been observed. If these symptoms occur, contact your doctor immediately. Symptoms usually resolve after discontinuation of the medicine. Your doctor will decide whether treatment should be discontinued.

Eye disorders
Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood sugar levels. Your doctor will decide whether treatment should be discontinued.

As with other sulfonylurea derivatives, the following adverse events have very rarely been observed (occurring in fewer than 1 in 10,000 people):
significant changes in blood cell counts and allergic vasculitis, decreased sodium concentration in blood (hyponatraemia), symptoms of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulfonylurea derivatives; however, in isolated cases, these may lead to life-threatening liver failure.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Gliclada

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the specified month.
No special storage instructions for the medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Gliclada contains

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• Other ingredients are: hypromellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2).

What Gliclada looks like and contents of the pack
Gliclada is a white to almost white, oval, biconvex tablet, 13 mm in length and 3.5 mm – 4.9 mm in thickness, with a score line on both sides. The tablet can be divided into equal doses.
Gliclada is available in packs containing 14, 15, 28, 30, 56, 60, 84, 90, 120 or 180 modified-release tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on product names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
29.07.2016